Massachusetts Licensed Medical Director

Job Summary

To support clinical development in the Rare Diseases therapy area, the part-time Massachusetts Licensed Medical Director will provide medical and scientific oversight, review phase III trial data, and ensure compliance with regulatory standards while working remotely on a contract basis.

Key responsibilities

• Review data from phase III trials and oversee CRO medical monitoring and safety coding for clinical research programs
• Collaborate with cross-functional teams to coordinate development and product support activities
• Provide expert medical advice and leadership for the development of clinical programs and review clinical protocols for accuracy

Required qualifications

• M.D. degree with a minimum of 3 years of clinical development experience
• Experience in conducting Phase III clinical trials and collaborating in a matrixed environment
• Familiarity with submissions of IND/CTX/NDA/MAA and interactions with regulatory authorities preferred
• In-depth understanding of drug development regulations and practices
• Strong judgment and decision-making skills with a proactive approach to team collaboration